Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020541
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARIMIDEX | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/27/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020541Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2018 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020541s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020541Orig1s031Ltr_rev1rev2cd.pdf | |
| 05/02/2014 | SUPPL-29 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020541s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020541Orig1s029ltr.pdf | |
| 05/01/2013 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020541s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020541Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/20541Orig1s027.pdf | |
| 04/18/2011 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020541s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020541s026ltr.pdf | |
| 04/30/2009 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf | |
| 04/30/2009 | SUPPL-24 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf | |
| 12/10/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020, s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/20541Orig1s023.pdf | |
| 12/10/2008 | SUPPL-21 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/20541Orig1s021.pdf | |
| 12/10/2008 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020, s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/20541Org1s020.pdf | |
| 05/10/2006 | SUPPL-18 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/16/2005 | SUPPL-16 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020541s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020541s016ltr.pdf | |
| 08/30/2004 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020541s015.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20541s015ltr.pdf | |
| 09/05/2002 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20541s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541se1-010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-541s010_Arimidex.cfm | |
| 09/10/2001 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/2001 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/2000 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20541S06LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex.cfm | |
| 10/07/2002 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541slr005,009ltr.pdf |
| 08/13/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/06/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/13/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020541s031lbl.pdf | |
| 05/02/2014 | SUPPL-29 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020541s029lbl.pdf | |
| 05/01/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020541s027lbl.pdf | |
| 04/18/2011 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020541s026lbl.pdf | |
| 04/30/2009 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf | |
| 04/30/2009 | SUPPL-24 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf | |
| 12/10/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf | |
| 12/10/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf | |
| 12/10/2008 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf | |
| 09/16/2005 | SUPPL-16 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020541s016lbl.pdf | |
| 08/30/2004 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020541s015.pdf | |
| 09/05/2002 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20541s10lbl.pdf | |
| 09/01/2000 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex_prntlbl.pdf |
ARIMIDEX
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 090568 | ACCORD HLTHCARE |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 206037 | BEIJING YILING |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 091164 | CIPLA |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 212434 | EUGIA PHARMA |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 078944 | KENTON |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 079220 | NATCO PHARMA LTD |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 078058 | TEVA PHARMS |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 078921 | ZYDUS PHARMS USA INC |
| ARIMIDEX | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 020541 | ANI PHARMS |